An interventional study of Arterial applanation tonometry and In vivo endothelial glycocalyx measurement in Preeclampsia and Hypertensive Disorder of Pregnancy, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Recruiting at 1 site in Italy. Open to female participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-22.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Not applicable, Interventional, and Prevention
Among 16 studies in Pre-Eclampsia with a site in Italy — 9 open to participants now, 10 under way, none of them phase 3. Pre-Eclampsia · Italy.
Among the 16 studies in Pre-Eclampsia with a site in Italy, this one is one of 4 that started in 2023, is one of 4 with no phase, and was the 8th registered.
916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.
Browse Pre-Eclampsia studies →9 of the 16 studies in Pre-Eclampsia with a site in Italy are open now. Recruiting first, the newest first:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Sites in Italy
Ages 18+ · Women only
IRCCS Burlo Garofolo · Sites in Italy
Ages 18+ · Women only
Istituto Clinico Humanitas · Sites in Italy
Ages 18+ · Women only · Healthy volunteers
IRCCS San Raffaele · Sites in Italy
Ages 18–45 · Women only · Healthy volunteers
Istituto Clinico Humanitas · Sites in Italy
Ages 18+ · Women only
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 162 Pre-Eclampsia studies recruiting now, 81 (50%) set no upper age limit and 80 (49%) stop at 75 or younger; 18 take children under 18; 60 take healthy volunteers.
This study: 18 Years to 65 Years · female · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
16 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 4 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 400 is above the median of 110 across 480 interventional studies indexed under Pre-Eclampsia.
Median enrollment 82 across the 6 interventional studies, 243 across the 10 observational. Of the 5 that completed or were terminated, 1 (20%) have results posted.
This tab as a report to print or save as PDF → With an account.
1 of 16 have an industry lead sponsor. The 10 most frequent:
IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 513 studies on the registry; 288 are open to participants now.
IRCCS Azienda Ospedaliero-Universitaria di Bologna has 1 study filed under Pre-Eclampsia — fewer than ten, so there is no comparison to draw.
3 of the studies in Pre-Eclampsia with a site in Italy that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07092644Fondazione Policlinico Universitario Agostino Gemelli IRCCSPreeclampsia and Fetal Heart Malformations: Looking to Maternal Heart | 2026-11 |
| NCT06317467IRCCS Burlo GarofoloRole of Anti-C1q Autoantibodies in Pregnancy | 2026-12 |
| NCT06893978Fondazione Policlinico Universitario Agostino Gemelli IRCCSPlacental Organoids Development: Application in the Study of the Human Reproduction Pathophysiology. | 2027-11 |
Add all 3 to your calendar (.ics) → With an account.
Among the 16 studies in Pre-Eclampsia with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The present study is a single-centre prospective study that will enrol pregnant women during their first trimester of pregnancy (11+0 - 13+6 weeks of gestation).
During pregnancy, women will undergo standard clinical evaluation and management. During the two study visits (enrollment and 24+0 - 27+6 weeks of gestation) the investigators will perform arterial tonometry (Pulsepen) and in vivo darkfield microscopy (Glycocheck) to evaluate endothelial and vascular function. A urine sample and a blood sample for specific study analyses on metabolic profile, endothelial and angiogenic markers will be collected. Pregnancy outcomes will be collected at delivery and five years after delivery all the participants will be interview to collect long-term cardiovascular outcomes. Serum endothelial and angiogenic markers will be evaluated only in participants who will develop hypertensive disorders of pregnancy and in an equal number of controls matched for age and body mass index at the time of conception.
Primary aim:
To determine the role of the combination of arterial tonometry and endothelial glycocalyx measurement in predicting the risk of developing hypertensive disorders in pregnancy.
Secondary aims:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The entire cohort of participants will undergo all experimental procedures. Participants who will develop hypertensive disorders of pregnancy and matched participants with healthy pregnancies will also undergo serum endothelial and angiogenic markers assessment.
Device: Arterial applanation tonometry · Device: In vivo endothelial glycocalyx measurement · Diagnostic Test: Serum markers of angiogenesis and endothelial dysfunction · Diagnostic Test: Blood chemistry test · Diagnostic Test: Serum xanthine oxidase activity
Arterial applanation tonometry will be performed at the carotid and femoral level by the PulsePen device (Software WPulsePen version 2.3.1, DiaTecne, Milan, Italy), while the subject is lying in the horizontal position and after 5 minutes of rest.
Also known as: PulsePen, Arterial stiffness measurement, Pulse wave velocity assessment
The in vivo microscopy (GlycoCheck system) is performed in the sublingual capillaries during the morning, with the participant sitting on a chair. The sublingual capillaries are visualized using an SDF video microscope (Capiscope handheld, KK Research technology Ltd).
Also known as: Glycocheck, Sidestream dark field microscopy
ELISA assays to measure serum circulating markers of angiogenesis and endothelial dysfunction (ANG-1, ANG-2, ET-1, ICAM-1 and VCAM-1).
Also known as: ANG-1, ET-1, ICAM-1, VCAM-1, ANG-2
Immunochemistry analysis of serum levels of uric acid, total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglycerides, Lipoprotein (a)
Serum xanthine oxidase (XO) activity will be assessed in blood samples measuring the ability of XO to produce uric acid
Perfused Boundary Region (PBR)
Micron
Time frame: Baseline visit (11/13+6 weeks of pregnancy)
Perfused Boundary Region (PBR)
Micron
Time frame: Follow-up visit (24/27+6 weeks of pregnancy)
Carotid-femoral pulse wave velocity (cf-PWV)
m/s
Time frame: Baseline visit (11/13+6 weeks of pregnancy)
Carotid-femoral pulse wave velocity (cf-PWV)
m/s
Time frame: Follow-up visit (24/27+6 weeks of pregnancy)
Number of participants with hypertensive disorders of pregnancy
Number of participants diagnosed during pregnancy with any hypertensive disorder of pregnancy
Time frame: From date of enrolment until the date of first documented diagnosis of hypertensive disorder of pregnancy, according to the International Society for the Study of Hypertension in Pregnancy Criteria, assessed up to one week after delivery
Number of participants with preeclampsia
Number of participants diagnosed during pregnancy with preeclampsia according to the International Society for the Study of Hypertension in Pregnancy (ISSHP) criteria.
Time frame: From date of enrolment until the date of first documented diagnosis of preeclampsia, according to the International Society for the Study of Hypertension in Pregnancy Criteria, assessed up to one week after delivery
Serum Angiopoietin 1 (ANG-1)
ng/ml
Time frame: Baseline visit (11/13+6 weeks of pregnancy)
Serum Angiopoietin 1 (ANG-1)
ng/ml
Time frame: Follow-up visit (24/27+6 weeks of pregnancy)
Serum Angiopoietin 2 (ANG-2)
ng/ml
Time frame: Baseline visit (11/13+6 weeks of pregnancy)
Serum Angiopoietin 2 (ANG-2)
ng/ml
Time frame: Follow-up visit (24/27+6 weeks of pregnancy)
Serum Endothelin-1 (ET-1)
Serum concentration assessed by ELISA (pg/ml)
Time frame: Baseline visit (11/13+6 weeks of pregnancy)
Serum Endothelin-1 (ET-1)
pg/ml
Time frame: Follow-up visit (24/27+6 weeks of pregnancy)
Serum Intercellular adhesion molecule-1 (ICAM-1)
ng/ml
Time frame: Baseline visit (11/13+6 weeks of pregnancy)
Serum Intercellular adhesion molecule-1 (ICAM-1)
ng/ml
Time frame: Follow-up visit (24/27+6 weeks of pregnancy)
Serum Vascular Cell Adhesion Molecule-1 (VCAM-1)
ng/ml
Time frame: Baseline visit (11/13+6 weeks of pregnancy)
Serum Vascular Cell Adhesion Molecule-1 (VCAM-1)
ng/ml
Time frame: Follow-up visit (24/27+6 weeks of pregnancy)
Number of participants with long-term cardiovascular outcomes
Number of participants diagnosed with stroke, myocardial infarction, heart failure or hospitalized for cardiovascular disease in the 5 years after delivery
Time frame: Interview 5 years after delivery
Serum uric acid
mg/dl
Time frame: Baseline visit (11/13+6 weeks of pregnancy)
Serum uric acid
mg/dl
Time frame: Follow-up visit (24/27+6 weeks of pregnancy)
Serum lipid profile
HDL-cholesterol (mg/dl), LDL-cholesterol (mg/dl), Triglycerides (mg/dl), Lipoprotein (a) (mg/dl)
Time frame: Baseline visit (11/13+6 weeks of pregnancy)
Serum lipid profile
HDL-cholesterol (mg/dl), LDL-cholesterol (mg/dl), Triglycerides (mg/dl), Lipoprotein (a) (mg/dl)
Time frame: Follow-up visit (24/27+6 weeks of pregnancy)
Xanthine Oxidase Activity
mU/mL
Time frame: Baseline visit (11/13+6 weeks of pregnancy)
Xanthine Oxidase Activity
mU/mL
Time frame: Follow-up visit (24/27+6 weeks of pregnancy)
Plan to share: Yes — All de-identified IPD that underlie results in a publication for all primary and secondary outcome measures will be shared.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data will be available after the associated manuscript will be published. No ad-interim analysis is planned before enrollment conclusion.
Access criteria: Access to IPD can be requested by qualified researchers engaging in independent scientific research, and provided after review and approval of a research proposal and execution of a Data Sharing Agreement (DSA).
No publications or documents are linked to this record.
Started Sep 2023 (actual). Primary completion is estimated for May 2026, 32 months after the start.
Of 171 non-industry interventional studies with no phase under Pre-Eclampsia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's planned 32 months is above that.
Counting every sponsor, half of 176 studies reached it within 24 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
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